A considerable amount of research effort has been directed towards the development of techniques to detect cancer cells or to distinguish between non-malignant and malignant cancer cells or tumors. For those patients with cancerous cells or tumors, it is important to determine which patients have the greatest risk for tumor progression or metastasis. For those patients, aggressive therapy, including surgery and chemotherapy, may be selectively employed. For patients demonstrating a lower risk of progression and metastasis, less aggressive therapy may be employed, particularly since progression or metastasis can now be readily monitored as provided in the present invention. Thus, one of the major problems of cancer treatment and research is the development of reliable and predictive methods of cancer detection.
Recently, various methods for analysing tumor specimens or exfoliated cells have been developed to detect genetic alterations, tumor suppressor genes, oncogenes, tumor cell products, and angiogenic factors. It is known that cancer progression in stage or grade is associated with increasing chromosomal anomalies that can be assessed by measuring tumor cell DNA content, by cytogenetic studies, or by measuring the function of activation in oncogenes and inactivation of tumor suppressor genes.
Masters et al., "DNA Ploidy and the Prognosis of Stage pt1 Bladder Cancer," i Br, J. Urolo. 64, 403 (1985), has used DNA measurements which show a correlation to tumor grade and recurrence rates. Norming et al., "Deoxyribonucleic Acid Profile and Tumor Progression in Primary Carcinoma in situ of the Bladder: A study of 63 Patients with Grade 3 Lesions," J. Urol. 147, 11 (1992), suggest that the number of aneuploid cell populations is an indicator for tumor progression.
In European Patent Application No. 203107 (PCT No. 8602651), International Publication No. W086/02651, having a priority date of Oct. 23, 1984, to Cramer et al., specific carbohydrate-binding proteins (lectin) of mammalian tumor cells are disclosed. Cramer et al. further suggests the possibility of the use of these lectins to provide corresponding monoclonal antibodies and subfragments of these antibodies through the use of hybridoma cell lines. It is also disclosed that these antibodies can be labeled with a fluorescent or radioactive group for use in an assay for tumors.
It would be desirable to provide other proteins and techniques for detecting human cancer cells and tumors. It would also be desirable to provide assay methods and kits with high reliability and low false positives for the detection of human cancer cells and tumors. It would also be desirable to provide assay methods and kits which are more discriminating to increases in the severity of cancerous development or progression. The present invention provides such proteins, techniques, assays, and kits for the detection of human cancer cells and tumors.